Europe’s population is becoming frail and less mobile as it ages, leaving us prone to accident and lifelong disability or reduced mobility. The SPRINTT project set out to better understand the problem of physical frailty and sarcopenia (muscle wasting), hoping that a clear and usable definition of the condition will help identify the exact target population that requires attention to avoid this fate. They set up a clinical trial with over 1,500 people to evaluate the effectiveness of a multi-component intervention at preventing mobility disability in an older population at risk of disability. They also designed a study to identify and validate diagnostic and prognostic biomarkers for physical frailty & sarcopenia.
Older people with physical frailty and sarcopenia are more vulnerable to mobility limitations and disability. Frail older people are also more likely to be hospitalised or to require long-term care in a nursing home. Yet, despite the devastating impact this condition has on older people's quality of life and the sustainability of healthcare systems, there is no formal, widely-accepted definition of frailty and no treatment to prevent its onset and progression. The SPRINTT project set out to define the specific characteristics of physical frailty and sarcopenia that can be easily applied in healthcare settings and to carry out a large clinical trial to assess treatment options designed to prevent loss of mobility.
The SPRINTT consortium demonstrated the existence of a specific population of vulnerable older adults at risk of negative outcomes. The operational definition of physical frailty and sarcopenia (PF&S) developed by the project members intercepts older adults in a critical but still reversible step of the disabling cascade. At this stage, different interventions (whether lifestyle modifications, pharmacologic strategies, or a combination) may be put in place to preserve mobility and, therefore, an independent lifestyle for a large share of older adults.
People with PF&S may be easily spotted in everyday life and the SPRINTT researchers developed an easy‐to‐use identikit to find them in the community. A prototypical person with PF&S is an old person who walks at a slow pace and who may or may not use a cane. They may need help rising from a chair, and they often hold the handrails while walking up and down stairs. People with PF&S may be overweight or underweight but have a low muscle function that impairs their way of moving freely and enjoying their life.
Unwittingly, people with PF&S are at high risk of incurring medical problems that may lead to hospitalisation or institutionalisation and require care, which makes them a subset of the older population with unmet medical needs. The defining criteria of PF&S are objective and measurable; in particular, the physical function domain of PF&S is assessed through the use of what’s known as the short physical performance battery (SPPB), a well‐known, standardised, easy‐to‐apply and highly reproducible set of functional tests.
The European Medicines Agency identified the SPPB as the preferred option to characterise functional performance and physical frailty in clinical trials in vulnerable older adults. It has a “prognostic value of disability and mortality; validation status; feasibility of use across all therapeutic areas; ease of use; time required; ease of investigator’s training; cost” that make the SPPB a full‐fledged functional biomarker of ageing.
The SPRINTT trial screened thousands of people and enrolled 1,519 people from 11 countries from across Europe, who were then randomly allocated to one of two groups. They tested the effects of a multicomponent intervention (MCI), based on physical activity, nutritional counselling, and information and communication technology solutions, in community‐dwelling older persons with PF&S in comparison with a healthy ageing lifestyle education (HALE) programme for preventing mobility disability. All participants were followed for at least two years.
Ultimately, they were able to show that a working definition of PF&S is possible, that the people in question are identifiable in the community, and finally, that something can be done to help them.
The trial demonstrated that a multimodal non-pharmacological intervention with diet and exercise really does work to prevent the development of mobility disability. This goes against a commonly held belief that this condition is an inevitable by-product of ageing and offers a lot of hope. According to the project coordinators, people not only benefitted from increased health and strength as a result of the interventions in the trial, but emotionally, too. The results of the SPRINTT trial are summarised in an article that was published in the prestigious British Medical Journal.
The project team will work closely with medicines regulators to ensure its findings can be rapidly implemented and applied to improve the development of innovative drugs for frailty. Ultimately, the outcomes of the SPRINTT project should result in improved treatment options and a better quality of life for the frail. Pharmaceutical industries and SMEs will also benefit from the project that established sound methodologies for developing innovative treatments for frailty and sarcopenia. A community was built around the project of adults enrolled in the trials that continues to thrive.
Achievements & News
IMI’s SPRINTT project has enrolled the first 500 participants in a pan-European study on whether it is possible to prevent physical disability in older people with physical frailty and sarcopenia (loss of muscle mass and strength).### The study, which should eventually recruit 1 500 participants over the age of 70 from across Europe, will compare two interventions. Some participants will follow a multi-component programme, based on exercise with a trainer plus a nutritional programme. Others will follow a healthy ageing lifestyle education programme. More information on the trial can be found on the project website.
ParticipantsShow participants on map
- Astellas Pharma Europe BV, Leiden, Netherlands
- Biophytis SA, Paris, France
- Boehringer Ingelheim Internationalgmbh, Ingelheim, Germany
- Glaxosmithkline Research And Development LTD., Brentford, Middlesex, United Kingdom
- Institut De Recherches Internationales Servier Iris, Suresnes, France
- Novartis Pharma AG, Basel, Switzerland
- Sanofi-Aventis Recherche & Developpement, Chilly Mazarin, France
Universities, research organisations, public bodies, non-profit groups
- Aston University, Birmingham, United Kingdom
- Centre Hospitalier Universitaire De Toulouse, Toulouse Cedex 09, France
- Diabetes Frail Limited, Droitwich, United Kingdom
- Friedrich-Alexander-Universitaet Erlangen-Nuernberg, Erlangen, Germany
- Haskoli Islands, Reykjavik, Iceland
- Medizinische Universitat Graz, Graz, Austria
- Universita Cattolica Del Sacro Cuore, Milan, Italy
- Universita Degli Studi Di Firenze, Florence, Italy
- Universita Degli Studi Di Parma, Parma, Italy
- Universitaetsmedizin Goettingen - Georg-August-Universitaet Goettingen - Stiftung Oeffentlichen Rechts, Goettingen, Germany
- Universite Paris Descartes, Paris , France
- Universiteit Maastricht, Maastricht, Netherlands
- University of Helsinki, University of Helsinki, Helsinki, Finland
- Univerzita Karlova, Prague 1, Czech Republic
- Uniwersytet Jagiellonski, Krakow, Poland
Small and medium-sized enterprises (SMEs)
- Caretek SRL, Torino, Italy
- Eu-Open SRL, veronella (Vr), Italy
- Roessingh Research And Development BV, Enschede, Netherlands
- Centre hospitalier universitaire de Limoges, Limoges, France
- Institut National De La Sante Et De La Recherche Medicale, Paris, France
Non EFPIA companies
- Istituto Nazionale Di Riposo E Cura Per Anziani Inrca, Ancona, Italy
- Servicio Madrileno De Salud, Madrid, Spain
|Name||EU funding in €|
|Aston University||76 892|
|Caretek SRL||2 522 000|
|Centre Hospitalier Universitaire De Toulouse||1 461 521|
|Diabetes Frail Limited||1 100 000|
|Eu-Open SRL||560 411|
|Friedrich-Alexander-Universitaet Erlangen-Nuernberg||1 462 794|
|Haskoli Islands||349 650|
|Istituto Nazionale Di Riposo E Cura Per Anziani Inrca||1 670 125|
|Medizinische Universitat Graz||352 050|
|Roessingh Research And Development BV||200 046|
|Servicio Madrileno De Salud||2 146 723|
|Universita Cattolica Del Sacro Cuore||4 623 897|
|Universita Degli Studi Di Firenze||253 290|
|Universita Degli Studi Di Parma||730 000|
|Universitaetsmedizin Goettingen - Georg-August-Universitaet Goettingen - Stiftung Oeffentlichen Rechts||1 513 500|
|Universite Paris Descartes||368 980|
|Universiteit Maastricht||704 088|
|University of Helsinki||1 492 749|
|Univerzita Karlova||757 192|
|Uniwersytet Jagiellonski||867 536|
|Name||Funding in €|
|Centre hospitalier universitaire de Limoges||522 746|
|Institut National De La Sante Et De La Recherche Medicale||263 249|
|Total Cost||23 999 439|